Assessing COVID-19 Risks and Hospitalization Outcomes
COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy
This study is testing a new way to track COVID-19 symptoms and risks using a mobile app, while also seeing if a specific drug can help reduce hospital visits for people who test positive for the virus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 27000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aventyn, Inc. Industry-sponsored |
| Locations | 3 sites (Phoenix, Arizona and 2 other locations) |
| Trial ID | NCT04678193 on ClinicalTrials.gov |
What this trial studies
This study aims to create a real-time epidemiology registry to evaluate COVID-19 risk assessment scores by recording symptoms, biomarkers, chronic illnesses, and mental health using digital technology. Researchers will monitor both PCR positive and negative subjects to understand variations in COVID-19 presentation and identify predictors for hospitalization and post-COVID complications. The study will also compare the efficacy of the ECL-19 drug against a placebo in reducing hospital admissions among COVID-19 positive patients. Participants can self-report their health status through a mobile app, enabling continuous monitoring and assessment.
Who should consider this trial
Good fit: Ideal candidates include individuals who are COVID-19 PCR positive, negative, or pending, as well as those with a high-risk score for COVID-19.
Not a fit: Patients who are unwilling to participate or considered unreliable for follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of COVID-19 risks and improve strategies to prevent hospitalizations.
How similar studies have performed: Other studies have shown promise in using digital health technologies for monitoring COVID-19, but this approach is innovative in its comprehensive risk assessment methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * COVID-19 PCR positive * COVID-19 PCR negative * COVID-19 PCR pending * COVID-19 high risk score Exclusion Criteria: * Subjects unwilling to participate in the study before, during or after consent * Patients considered unreliable by the investigator concerning the requirements for follow-up visits.
Where this trial is running
Phoenix, Arizona and 2 other locations
- Multiple Locations — Phoenix, Arizona, United States (Recruiting)
- Multiple Locations — Bangalore, India (Recruiting)
- Multiple Locations — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Hans A Vink, PhD — Maastricht University
- Study coordinator: Kris Vijay, MD
- Email: coromec@aventyn.com
- Phone: 2317942328
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.